REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

Description

The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life. 1. Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care? 2. Among patients with Fontan failure, will cardiac rehabilitation improve exertional tolerance (as measured by cardiopulmonary exercise testing), frailty, and self-reported quality of life metrics compared to usual care?

Conditions

Heart Failure Congenital, Single-ventricle

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Study Overview

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Study Details

Study overview

The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life. 1. Among patients with Fontan failure, will cardiac rehabilitation increase average daily steps compared to usual care? 2. Among patients with Fontan failure, will cardiac rehabilitation improve exertional tolerance (as measured by cardiopulmonary exercise testing), frailty, and self-reported quality of life metrics compared to usual care?

RCT of the Effects of Cardiac reHABilitation (REHAB) Among Patients With Fontan Failure

REHAB Fontan Failure: A Trial of Cardiac Rehabilitation

Condition
Heart Failure Congenital
Intervention / Treatment

-

Contacts and Locations

Stanford

Stanford University, Stanford, California, United States, 94305

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Fontan failure, defined as history of a Fontan procedure and at least one of the following: systemic ventricular EF \<50% (by echocardiography, cardiac magnetic resonance imaging, or computer tomography), protein losing enteropathy, plastic bronchitis, chronic loop diuretics prescribed by ACHD Cardiologist, and/or peak VO2 \< 50% predicted (by FRIEND equation)
  • * Age \>= 18 years old
  • * Inotrope-dependence
  • * Symptomatic, uncontrolled arrhythmias
  • * Pregnancy
  • * Contraindication to cardiac rehab or already enrolled in cardiac rehabilitation
  • * Inability to comply with the protocol
  • * Recent (\<3 months) planned Fontan pathway percutaneous or surgical intervention
  • * Resting hypoxemia with baseline oxygen saturation \<80%

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Stanford University,

Daniel E Clark, MD, MPH, PRINCIPAL_INVESTIGATOR, Stanford University

Jonathan N Menachem, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

2025-12-31